Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Multimodal Intervention.
- Who it may be relevant to
- Registry conditions: Cognitive Impairment, Dementia, Artificial Intelligence (AI), Stroke. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) in High Stroke-risk Population: a Randomized Trial
Overview
This randomized controlled trial will enroll individuals aged ≥ 40 years without dementia who are at high risk for stroke, collecting multi-modal MRI imaging, serum, and fecal samples to investigate the effects of a smartphone-based multimodal health intervention on cognitive function measured using digital-evaluated cognitive scores.
Detailed description
The Smartphone-based multimodal Health Intervention for Neurological Enhancement (SHINE) trial is designed to test the impact of a 6-month artificial intelligence(AI)-assisted intervention utilizing smartphone-based multimodal lifestyle and stroke risk factor management on 1036 participants aged 40 years and above who are without dementia and are at high risk for stroke. The multimodal digital program integrated adaptive cognitive training, personalized cardiovascular risk management, smart wristband-based physical activity and sleep monitoring, and dietary guidance, all delivered through a smartphone application incorporating behavioral change and AI techniques. Participants in the intervention group will receive the lifestyle and stroke risk factors management, while participants in the control group will receive standard educational materials and care. The investigation will explore potential mediators and modifiers of the intervention's effects by collecting various cardiovascular risk factors, serum samples, fecal samples, neuropsychological assessment results, and multi-modal magnetic resonance imaging at baseline, 6 months, 1 year, and 2 years.
Interventions
- Behavioral Digital Multimodal Intervention
Participants will undergo a 6-month multimodal intervention via a digital platform, which includes: (1) Personalized cognitive training; (2) Self-monitoring and management of stroke risk factors including hypertension, dyslipidemia, diabetes, smoking and obesity; (3) Smart wristband-based exercise monitoring and management; (4) Smart wristband-based sleep monitoring and management; (5) Health dietary recording and guidance
Primary outcome measures
- Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol [Time frame: 6 months]
Secondary outcome measures (12)
- Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) [Time frame: 6 months, 1 year, 2 years]
- Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) [Time frame: 6 months, 1 year, 2 years]
- Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples [Time frame: 6 months, 1 year, 2 years]
- The Oriental Intervention for Enhanced Neurocognitive health (ORIENT) diet score (minimum value = 0, maximum value = 14, and higher scores mean a better outcome) [Time frame: 6 months, 1 year, 2 years]
- Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome) [Time frame: 6 months, 1 year, 2 years]
- Dementia and cerebrovascular events incidence [Time frame: 2 years, 5 years]
- Gut microbiota determined by measuring specific bacterial levels in the fecal samples [Time frame: 6 months, 1 year, 2 years]
- Frequency of digital platform usage for lifestyle and risk factor management (number of weekly platform feature accesses, tracked through platform analytics) [Time frame: 6 months, 1 year, 2 years]
- Completeness of data uploads on digital platform [Time frame: 6 months, 1 year, 2 years]
- Change in waist circumference if overweight/obese [Time frame: 6 months, 1 year, 2 years]
- Change in body mass index (BMI) if overweight/obese [Time frame: 6 months, 1 year, 2 years]
- working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) [Time frame: 6 months, 1 year, 2 years]
Eligibility criteria
Inclusion criteria
- Patients aged ≥ 40 years
- High risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
- Written informed consent available
- Primary school education or above
- Proficient in using smartphones
- Willingness to complete all assessments and participate in follow-up
Exclusion criteria
- previously diagnosed dementia
- Suspected dementia after clinical assessment by study physician at screening visit
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- Severe loss of vision, hearing, or communicative ability
- Patients presenting a malignant disease with life expectancy < 3 years
- Participation in an ongoing investigational drug study
Exit Criteria:
- Not meet the inclusion criteria
- For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
- Any adverse or serious adverse events during the study period judged by Investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Second Affilated Hospital of Zhejiang University, School of Medicine — Hangzhou
Identifiers
NCT: NCT07092371 · SHINE